NCT02793349

Brief Summary

ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

June 3, 2016

Last Update Submit

April 15, 2019

Conditions

IschemiaPeripheral Arterial Disease (PTAArterial Occlusive Diseases

Keywords

angioplastystentspolymersabsorbable implants

Outcome Measures

Primary Outcomes (1)

  • Angiographic patency

    Freedom from angiographic binary in-scaffold restenosis (\>50% stenosis)

    12 months

Secondary Outcomes (10)

  • Technical success

    Procedure

  • Haemodynamic primary, assisted primary and secondary patency

    1 month

  • Haemodynamic primary, assisted primary and secondary patency

    6 months

  • Haemodynamic primary, assisted primary and secondary patency

    12 months

  • Haemodynamic primary, assisted primary and secondary patency

    24 months

  • +5 more secondary outcomes

Study Arms (1)

Bioresorbable Vascular Scaffold

EXPERIMENTAL

Absorb Bioresorbable Vascular Scaffold

Device: Absorb Bioresorbable Vascular Scaffold

Interventions

Absorb Bioresorbable Vascular ScaffoldDEVICE

Absorb Bioresorbable Vascular Scaffold

Also known as: BVS
Bioresorbable Vascular Scaffold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stenotic (\> 50%) or occlusive atherosclerotic disease of the distal popliteal or infrapopliteal arteries
  • A maximum of two focal target lesions in one or more distal popliteal or infrapopliteal vessels
  • Length of lesion is maximally 55 mm, allowing maximally 2 stents to be implanted
  • Reference vessel diameter should be 2.5 mm-4 mm
  • Symptomatic critical limb ischemia (Rutherford 3, 4, 5)
  • Subject is able to take at least one type of thienopyridine (e.g. clopidogrel) and acetylsalicylic acid
  • The patient must be \> 18 years of age
  • Life-expectancy of more than 12 months
  • The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
  • The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
  • The patient must provide written patient informed consent that is approved by the ethics committee

You may not qualify if:

  • Patient refusing treatment
  • The reference segment diameter is not suitable for available stent design.
  • Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis
  • Untreatable lesion located at the distal outflow arteries
  • More than two infrapopliteal lesions in the same limb
  • Previously implanted stent(s) or PTA at the same lesion site
  • Lesion location requiring kissing stent procedure
  • Lesion lies within or adjacent to an aneurysm
  • Inflow-limiting arterial lesions left untreated
  • The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
  • The patient takes Phenprocoumon (Marcumar).
  • The patient has a history of prior life-threatening contrast media reaction.
  • The patient is currently enrolled in another investigational device or drug trial.
  • The patient is currently breast-feeding, pregnant or intends to become pregnant.
  • The patient is mentally ill or retarded.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Prince of Wales Hospital

Sydney, New South Wales, 2031, Australia

Location

Epworth Hospital

Melbourne, Victoria, 3121, Australia

Location

Reinier de Graf Hospital

Delft, 2625AD, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

IschemiaPeripheral Arterial DiseaseTruncus Arteriosus, PersistentArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesAortopulmonary Septal DefectHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ramon L Varcoe, MS,FRACS,PhD

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 8, 2016

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

NZ(1)NL(1)AU(2)